PACE: cluster randomised controlled trial on ‘PACE Steps to Success' palliative care programme in Long Term Care Facilities in Europe

• Register: ISRCTN
• Last refreshed on: 31 October 2022
• Main ID: ISRCTN14741671
• Date of registration: 30/07/2015
• Prospective Registration: No
• Primary sponsor: European Commission
• Public title: PACE: cluster randomised controlled trial on ‘PACE Steps to Success' palliative care programme in Long Term Care Facilities in Europe
• Scientific title: Comparative Effectiveness Research in long term care facilities in Europe - randomised controlled cluster trial on ‘PACE Steps to Success' palliative care programme
• Date of first enrolment: 01/06/2015
• Target sample size: 80
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN14741671
• Study type: Interventional
• Study design: A randomized controlled cluster trial using pre- and post-measurement of relevant outcome variables, process evaluation and economic evaluation to determine the intervention effects. It will use a sample of LTCFs fitting a number of inclusion criteria from a predetermined geographical region in each of the 7 participating countries. (Other)
• Phase: Not Applicable

Countries of recruitment

Belgium, England, Finland, Italy, Netherlands, Poland, Switzerland, United Kingdom

Contacts

• Name: Bregje Onwuteaka-Philipsen

• Name: Yuliana Gatsolaeva

Key inclusion & exclusion criteria

Inclusion criteria:
To enhance comparability between countries, LTCFs are eligible to be recruited when they fulfil all of the following inclusion criteria:
1. An off-site family physician or GP is responsible for the resident’s medical care.
2. Social and nursing care is provided onsite .
3. Number of beds per facility is at least 30 but does not exceed 100.
4. We strive to include facilities with at least 15 deceased residents in or outside the facility over the last year. If it is not possible to find enough LTCFs that fit this inclusion criterion, facilities should be selected in which the number of deceased residents in the past year is closest to 15.
5. LTCFs from a predefined geographical location (to be determined by the researchers).
6. Each partner lists all LTCFs fitting these inclusion criteria. From this list, only those LTCFs where the Board of Directors (1) expresses explicit motivation to participate in the study and (2) agrees to free time for one PACE coordinator for e.g. 0.5 days per working week, depending on setting, will be included in the study.

Exclusion criteria: Researchers exclude facilities already using a palliative care planning tool e.g. (accredited users of) the Gold Standards Framework, Route to Success, Six Steps to Success, interRAI-PC version or end of life care integrated pathways such as Liverpool Care Pathway; or those facilities where they judge explicit and detailed palliative care guidelines to be available and corresponding high-quality practices to be implemented.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Older people living in long term care facilities
Not Applicable

Intervention(s)

In each country, six of 12 LTCFs will be randomized to the intervention group, in which they will receive the support of a Country Trainer and with the aid of a self-appointed PACE coordinator in the facility, will implement the ‘PACE Steps to Success’ palliative care programme. The other six LTCF will be randomized to the control group, in which care will be provided as usual.

The intervention ‘PACE Steps to Success’ palliative care programme aims to integrate palliative care in day-to-day routines of staff working in LTCFs, to ensure behavioural sustainability. At the core of the intervention is the nomination of a Representative for palliative care from the LTCF (named PACE coordinator in a facility). These coordinators are supported to develop their knowledge and skills and encouraged to empower staff within their organisation to deliver palliative care. All staff in the LTCF are supported by a Country Trainer who delivers workshops and provides support and education to all staff.

The timing of the intervention is as follows (total duration of 12 months):
- A two-month pre-implementation phase. During this phase PACE coordinators will get a “pre-intervention training” given by the Country trainer.
- A six month implementation of the intervention, with one step of the intervention being delivered every month. The implementation phase consists of six 90 minute workshops for nursing staff given by the Country trainer. Each workshop covers one of the six steps to deliver quality care for people dying in the facility. Each of the six steps of the intervention is related to a key element of the intervention. Within the workshops, the materials and tools that LTCFs can use are introduced.

Primary Outcome(s)

1. Quality of dying of the residents is measured using structured after-death questionnaires including validated instruments like EOLD-CAD (End-Of-Life in Dementia - Comfort Assessment in Dying) and QOD-LTC (Quality of Dying in Long-Term Care) at baseline, month 13 and month 17 after the start of the trial period
2. Staff knowledge and attitudes is measured using structured questionnaires including validated instrument like the ECPS (End-of-Life Professional Caregiver Survey), PCS (Palliative Care Survey) and S-EOLC (Self-Efficacy in End-of-Life Care Survey) at baseline and month 13 after the start of the trial period

Secondary Outcome(s)

Quality of palliative care is measured using structured after-death questionnaires including validated instruments like EOLD-SWC (End-Of-Life in Dementia - Satisfaction With Care) and FPPFC (Family Perception of Physician-Family Communication) at baseline, month 13 and month 17 after the start of the trial period.

Secondary ID(s)

FP7-HEALTH-2013-INNOVATION-1 603111

Source(s) of Monetary Support

European Commission (7th Framework Programme, Health 2013 Innovation, and Grant Agreement No: 603111), Swiss Academy for Medical Sciences

Ethics review

Status:
Approval date:
Contact:

1. Netherlands: Medical Ethics Review Committee of VU University Medical Center, 02/07/2015, ref: 2015.253 2. Belgium: Medical Ethics Committee of Brussels University Hospital (Vrije Universiteit Brussel), 27/05/2015, ref: 143201524752 3. Finland: Research Ethics Committee of the National Institute for Health and Welfare, 30/06/2015, ref: THL/850/6.02.01/2015 4. Poland: Bioethics committee of the Jagiellonian Univer

Results

• Results available: Yes
• Date Completed: 31/07/2018